Class II · Moderate risk
Magnesia Phosphorica 6X Tablets
CGMP Deviations: products were not manufactured under current good manufacturing practices.
FDA Drug Recalls
1,563 recalls, newest first
Class II · Moderate risk
Kali Sulphuricum 6X Tablets
CGMP Deviations: products were not manufactured under current good manufacturing practices.
Class II · Moderate risk
Kali Phosphoricum 6X Tablets
CGMP Deviations: products were not manufactured under current good manufacturing practices.
Class II · Moderate risk
Kali Muriaticum 6X Tablets
CGMP Deviations: products were not manufactured under current good manufacturing practices.
Class II · Moderate risk
Ferrum Phosphoricum 6X Tablets
CGMP Deviations: products were not manufactured under current good manufacturing practices.
Class II · Moderate risk
Cell Salts Combination 6X Tablets
CGMP Deviations: products were not manufactured under current good manufacturing practices.
Class II · Moderate risk
Calcarea Sulphurica 6X Tablets
CGMP Deviations: products were not manufactured under current good manufacturing practices.
Class II · Moderate risk
Calcarea Phosphorica 6X Tablets
CGMP Deviations: products were not manufactured under current good manufacturing practices.
Class II · Moderate risk
Calcarea Fluorica 6X Tablets
CGMP Deviations: products were not manufactured under current good manufacturing practices.
Class II · Moderate risk
GSMS: Ranitidine Capsules 300 mg
CGMP Deviations: Presence of NDMA impurity detected in product.
Class II · Moderate risk
GSMS: Ranitidine Capsules 150 mg
CGMP Deviations: Presence of NDMA impurity detected in product.
Class II · Moderate risk
Valganciclovir Hydrochloride for Oral Solution
Presence of foreign substance: Brown/black particles found during stability testing.
Class II · Moderate risk
Ranitidine Syrup
CGMP Deviations: Presence of NDMA impurity detected in product.
Class II · Moderate risk
Hydrocodone Bitartrate and Homatropine Methlybromide Oral Solution 5 mg/1.5 mg per 5 mL
Presence of Foreign Substance: Black particles were found in the lots during retain sample inspection
Class III · Low risk
Cefdinir for Oral Suspension USP
Presence of Foreign substance: identified as a dead ant.
Class III · Low risk
Cefdinir for Oral Suspension USP
Presence of Foreign substance: identified as a dead ant.
Class III · Low risk
Cephalexin for Oral Suspension USP
Presence of Foreign substance: identified as a dead ant.
Class II · Moderate risk
LETS GEL KIT Convenience Pack
Microbial contamination of non-sterile product.
Class II · Moderate risk
Potassium Phosphate
Failed Stability Specifications: Product exceeds compendia and firm's specifications for iron content.
Class II · Moderate risk
Lannett Ranitidine Syrup
CGMP Deviations: Presence of NDMA impurity detected in product.
Class I · High risk
0.9% Sodium Chloride Injection
Presence of Particulate Matter.
Class I · High risk
LACTATED RINGER'S Injection
Presence of Particulate Matter.
Class II · Moderate risk
Novitium Pharma Ranitidine Capsules 300 mg 100 capsules Rx Only…
CGMP Deviations: Presence of NDMA impurity detected in product.
Class II · Moderate risk
Novitium Pharma Ranitidine Capsules 300 mg 30 capsules Rx Only…
CGMP Deviations: Presence of NDMA impurity detected in product.
Class II · Moderate risk
Novitium Pharma Ranitidine Capsules 150 mg 500 capsules Rx Only…
CGMP Deviations: Presence of NDMA impurity detected in product.